With more than one million page views and more than 4,000 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Tuesday, February 24, 2015

The U.S. Supreme Court yesterday appeared to have put an end to a
California’s group nine-year effort to overturn patents on human embryonic stem
cells held by the Wisconsin Alumni Research Foundation (WARF).

The court refused to hear the case that was brought by
Consumer Watchdog of Santa Monica, Ca., and Jeanne Loring, head of the stem
cell program at Scripps. The court issued its decision with no comment.

“The high court's denial leaves in place a ruling last year
by the U.S. Court of Appeals for the Federal Circuit, which found that Consumer
Watchdog lacked standing to appeal the findings of the PTO's (Patent and
Trademark Office) administrative patent review board.”

Royalties from WARF patents in California alone generated an
estimated $200 million in 2006 for the foundation. Executives of biotech firms
in California have complained that WARF’s restrictions have posed a significant
barrier to private investment.

Asked for comment, Loring said,

"This doesn't mean they believe that human cells can or cannot be patented, but only that they decided that we had not been sufficiently harmed by the patent for them to become involved.

"Even without a Supreme Court decision, we have succeeded. WARF wanted their patents to include iPS cells as well as ES cells, but they had to narrow their claims as a result of our challenge, and they cannot claim ownership of iPSCs."

Doing the legal lifting in the WARF challenge was Dan
Ravicher, executive director of the Public Patent Foundation of New York.
Shuchman carried a comment from Ravicher on yesterday’s ruling. She wrote,

“Ravicher said Monday that the Supreme Court's decision
could impact many would-be patent challengers. ‘This case could have severe
consequences for other third parties that challenge patents with IPRs or the
other proceedings created under the America Invents Act,’ Ravicher said. ‘Now
they will have no right to appeal an adverse decision.’

“But he also said the decision wouldn't preclude individuals
who can claim direct harm, such as stem cell research scientists, from
challenging WARF's patent—much the same way doctors successfully challenged the
Myriad patents.

“Under the America Invents Act, third parties, such as
nonprofits, public interest groups and industry organizations, have the right
to challenge patents at the PTAB (Patent Trial and Appeal Board). But under the
Federal Circuit’s ruling that now stands, they don't have the right to appeal a
PTAB decision.”

Shuchman also recounted briefly some unusual history on the
federal appellate ruling that declared Consumer Watchdog had no standing to
sue. A more detailed account of that hearing can be found here.

The California Stem Cell Report has asked Consumer Watchdog and WARF for comments. We will carry them when we receive them. Here is the full text of what Loring had to say.

"Being involved for nearly 9 years in the challenge of WARF's patent
on human ES cells has given me a fascinating glimpse into our legal
system. I hoped that the Supreme Court would decide on the patentability
of human embryonic stem cells. But ultimately, the Court decided not to
take our case. This doesn't mean they believe that human cells can or
cannot be patented, but only that they decided that we had not been
sufficiently harmed by the patent for them to become involved. Even
without a Supreme Court decision, we have succeeded. WARF wanted their
patents to include iPS cells as well as ES cells, but they had to narrow
their claims as a result of our challenge, and they cannot claim
ownership of iPSCs.

"I've learned that the law
is every bit as complex as scientific research, and have gained great
admiration for people like our attorney, Dan Ravicher, who relentlessly
pursue the question of patent ethics - what should and should not be
patented in the public interest. Dan brought the issue of patenting the
human genome to the Court, and won (the Myriad Genetics case). Working
on this challenge with Dan and John Simpson (of Consumer Watchdog) has been a joy, and if they
ever want my help in the future, I'd agree in a second."

About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.